510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801950Substantially Equivalent

Bcm-600 Mini-Six Extra Lg. Field Angio

B C Medical, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801950 is the FDA 510(k) clearance record for BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO, a class II device, cleared for B C Medical , Ltd. on under FDA product code KPX (Changer, Radiographic Film/Cassette). FDA records list 8 510(k) clearances for B C Medical , Ltd., from to . As of , FDA records show no recalls naming K801950.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KPX Changer, Radiographic Film/Cassette
Regulation
21 CFR 892.1860
Device class
Class II
Review panel
Radiology
Applicant
B C Medical , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPX

Trailing 12 months

FDA records hold no clearances under product code KPX in the trailing twelve months.

FDA records show no clearances under product code KPX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260